(23 days)
The indications for use for the 3-Piece Proximal Humeral Replacement System include noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis, theumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, treatment of acute fractures with humeral head involvement which are unmanageable using other treatment methods and oncology applications.
The 3-Piece Proximal Humeral Replacement System is for use with bone cement.
The 3-piece Proximal Humeral Replacement System is a total shoulder prosthesis humeral component in cases where there has been severe proximal bone loss due to a tumor, trauma, or previous device placement.
The modified proximal humeral replacement device can be a combination of a proximal body and stem or proximal body, segment, and stem. The device is designed so that the distal portion of the stem is cemented into the remaining humeral bone with the stem collar, segment, and proximal body residing above the natural bone.
The provided text is a 510(k) summary for a medical device called the "3-piece Proximal Humeral Replacement System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through clinical trials in the way artificial intelligence (AI) or diagnostic devices typically do.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this 510(k) submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission of this type (proximal humeral replacement system), the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing that the new device has the same intended use, technological characteristics (materials, design, sizing), and performs as safely and effectively as the predicate device.
- Reported Device Performance: The primary "performance" reported is related to mechanical testing and the assertion that the device's characteristics are similar or identical to the predicate.
| Acceptance Criterion (Primary for 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Substantial Equivalence to Predicate | "The 3-piece Proximal Humeral Replacement System components—the materials, design, sizing, and indications are similar or identical to the predicate devices." |
| Mechanical Testing Sufficiency | "Mechanical Testing with Engineering Justifications determined that the 3-piece Proximal Humeral Replacement to the predicate device presented no new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- N/A. This submission did not involve a clinical "test set" in the context of an AI or diagnostic device study. The substantial equivalence was based on design, materials, and mechanical testing, not on clinical performance data from a specific patient cohort. The "test set" for mechanical testing would refer to the number of devices mechanically tested, but this detail is not provided in the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. As no clinical test set requiring ground truth was presented, no experts were needed for this purpose.
4. Adjudication Method for the Test Set
- N/A. No clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI or diagnostic device; therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- N/A. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used
- N/A. No ground truth in the context of clinical performance was established for the 510(k) submission. The "ground truth" for substantial equivalence was based on the known, legally marketed predicate device's characteristics and performance, and the mechanical testing of the new device showing similar safety and effectiveness.
8. The sample size for the training set
- N/A. This refers to AI algorithms, which is not applicable here.
9. How the ground truth for the training set was established
- N/A. Not applicable.
Summary of the Study (as described in the 510(k) submission):
The study supporting this 510(k) submission primarily consisted of:
- Comparison to a Predicate Device: The manufacturer demonstrated that the new 3-piece Proximal Humeral Replacement System is "substantially equivalent" to an existing, legally marketed device (the "Proximal Humeral Replacement System," K925613). This involved showing that the new device has similar or identical materials, design, sizing, and indications for use.
- Non-Clinical Mechanical Testing: Mechanical testing with engineering justifications was performed. The conclusion was that this testing "presented no new questions of safety or effectiveness" compared to the predicate device.
- No Clinical Testing: The submission explicitly states, "No clinical testing was provided as a basis for substantial equivalence." This is common for 510(k)s where substantial equivalence can be demonstrated through non-clinical means and comparison to a well-established predicate device.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”